90% of clinical trials fail.1 Roughly half of those failures are due to lack of clinical efficacy and another third due to intolerable side effects or high toxicity levels. Considering the persistent lack of diversity and underrepresentation of ethnic minorities in clinical trials,2 which limits the applicability of the results, these outcomes are not surprising.
Compounding this is the high costs that research and development can reach. The cost to develop a new drug can range from $1.31 – $2.23 billion,3,4 depending on methodologies used to measure the costs (with some treatments costing significantly more to develop). Furthermore, it can take anywhere between 10 – 15 years to bring a new therapy to market, with an average of about 8 years of those is spent in clinical trials (Phases 1 – 3).
The numbers don’t lie – the current model is unsustainable. Change is imperative.
Investing In: Decentralized Clinical Trial (DCT) Elements
DCTs are not new. In fact, next year (2026) MRN will have been delivering DCTs for two decades. However, it is only in the last few years, accelerated by the necessity of the pandemic, that they have moved from a niche, specialist offering to a mainstream alternative to the traditional site-centric model.
DCTs have also evolved over time. No longer viewed as a single solution, they represent an umbrella of flexible elements that can decentralize a trial fully or partially, depending on the study design and patient needs. These elements include in-home visits, telehealth, mobile research nursing, remote monitoring, digital endpoints, and more.
And patients have responded positively. One study found that 65.9% of patients preferred a hybrid model, and overall patient receptivity increased when the trial experience was personalized to meet individual needs.6 By putting patients in the driving seat of how and where they receive care, DCTs directly address two major barriers to recruitment and retention: burdensome logistics and poor patient experience.
DCT options can also greatly increase patient reach. In-home visits, telehealth, and remote monitoring, bring studies to populations who may never have participated otherwise, enabling sponsors to tap into more diverse pools and gather much-needed real-world data (RWD). Home-visiting healthcare professionals (HCPs) add an additional layer of value, and provide enhanced data quality, by observing patient behavior, environment, and response to investigational products (IP) in real time – insights that traditional site visits often cannot capture.
However, DCTs are not plug-and-play, nor are they one-size-fits-all. Sponsors must strategically implement DCT elements where they will have the greatest impact and effective implementation requires early planning and strategic integration into the trial design – not retrofitting once issues arise. Leveraging experienced partners like MRN can make all the difference. Organizations with deep DCT expertise can guide sponsors on which elements best fit the protocol, how to manage them operationally, and how to ensure they remain compliant under various global regulatory authority requirements.
Investing In: Community-focused Site Networks
Traditional site networks tend to comprise of academic medical centers and large hospitals or focus on specific therapeutic indications. Community-focused site networks, in contrast, are far more diverse and accessible. They include local clinics, community labs, pharmacies, flexible satellite sites, and even trial-naïve practices.
This community-driven approach meets patients where they already receive care. By reducing dependency on high-density research hubs sponsors can engage with populations historically underrepresented or even excluded from clinical trials due to geography, socioeconomic barriers, or access-related barriers.
Equally important, community sites foster trust in ways traditional sites often cannot. Patients are significantly more likely to participate in research, and remain engaged, when approached by providers they already know and who understand their cultural context, communicate preferences, and community needs.
Community-based networks, especially when integrated with DCT elements, are demonstrating their ability to drive both diversity and scale, helping to build a more resilient, patient-centric clinical trial ecosystem.7
Investing In: Patient-Centric Infrastructure and Operational Excellence
The final, and arguably the most overlooked, piece of the modern clinical trial puzzle is the operational infrastructure required for trials to run smoothly at scale. Delivering these new models effectively requires comprehensive solutions, including:
- Training & upscaling community and trial-naïve sites
- Ensuring consistent data quality across diverse settings
- Implementing robust logistics and supply-chain solutions for in-home and remote trial “visits”
Without proper planning, coordination, and integration, the full potential of community site networks, as well as hybrid and decentralized trials can become fragmented, inconsistent, or non-compliant, and their potential will not be realized.
This is where specialized partners play a critical role. Organizations with deep experience in decentralized trial delivery, global home-health operations, and community-based research can help sponsors design, operationalize, and scale hybrid trial models that actually work. They understand the nuances, from regulatory variations and patient safety considerations to data integrity and the complex logistics of moving research out of centralized sites and into patients’ lives.
The Bottom Line
The industry can no longer afford the inefficiencies that have become normalized. The numbers don’t lie, and they paint a picture of a system where traditional models are no longer working optimally.
Yet the industry is not without solutions; by strategically investing in decentralized trial elements, building community-focused site networks, and strengthening the infrastructure that supports patient-centric research, we can create clinical trial models that are more inclusive, more efficient, and more likely to succeed.
The future of clinical trials will be defined by flexibility, equity, and patient empowerment. The transformation is already underway—now it’s time to accelerate it.
Show me how MRN can work with me to reach and retain more patients.
References:
- Sun D, et al. Why 90% of clinical drug development fails and how to improve it? Acta Pharm Sin B. 2022 Jul;12(7):3049-3062. doi: 10.1016/j.apsb.2022.02.002.
- Kelsey MD, et al. Inclusion and diversity in clinical trials: Actionable steps to drive lasting change. Contemp Clin Trials. 2022 May;116:106740. doi: 10.1016/j.cct.2022.106740.
- Mulcahy A, et al. Use of Clinical Trial Characteristics to Estimate Costs of New Drug Development. JAMA Netw Open. 2025 Jan 2;8(1):e2453275. doi: 10.1001/jamanetworkopen.2024.53275
- Deloitte News. Global pharma R&D returns rise as GLP-1 drugs help drive forecast growth. Mar 2025. https://www.deloitte.com/uk/en/about/press-room/global-pharma-rd-returns-rise-as-one-glp-drugs-help-drive-forecast-growth.html. Last Accessed December 2025.
- Chatterjee B, et al. Industry Perspective – What does Industry Need to Accelerate Drug Product and Process Development? Pharm Res. 2024 Jan;41(1):7-11. doi: 10.1007/s11095-023-03604-y.
- Nguyen VT, et al. Patients’ Perspectives on Transforming Clinical Trial Participation: Large Online Vignette-based Survey. J Med Internet Res. 2022 Feb 1;24(2):e29691. doi: 10.2196/29691. PMID: 35103603; PMCID: PMC8848233.
- Medical Research Network. Unlocking Recruitment Potential In Trial-Naïve Sites With MRN Site Professional Support. https://themrn.io/newsroom/resources_posts/unlocking-recruitment-potential-in-trial-naive-sites-with-mrn-site-professional-support/. Last Accessed December 2025.